On July 6, 2022, the Ministry of Health of the Republic of Indonesia issued Decree KMK RI Number HK.01.07/Menkes/1258/2022 concerning the substitution of imported medical devices with domestic medical devices in the Health Sector E-Catalog. Subsequently, on July 28, 2022, the Ministry invited members of GAKESLAB Indonesia, the Association of Indonesian Medical Device Manufacturers (ASPAKI), the Association of Indonesian Medical Gas Installations (AIGMI), members of the Association of Indonesian Optical Entrepreneurs (Gapopin), and leaders of medical device businesses to participate in the socialization of this decree.

The primary objective of this initiative is to enhance health resilience and promote the growth of the domestic medical device industry. It is essential to prioritize the use of domestic medical devices in implementing government policies through the Health Sector E-Catalog. A variety of local medical devices are available in this catalog, making it crucial to decide how to replace imported medical devices with local alternatives. A decree from the Minister of Health is required to facilitate this substitution process.

Mechanism Of Freeze and Unfreeze

The substitution of imported medical devices with domestic products in the Health Sector E-Catalog will utilize the mechanisms of Freeze and Unfreeze. Several benchmarks will guide the execution of these mechanisms:

• FreezeThis mechanism will be implemented if a medical device product that meets health service needs has been produced domestically and holds a distribution permit, or if the production capacity of the medical device fulfills the plan for the required specifications.
• This mechanism will apply to imported products if the domestic medical device industry's production capacity has not met national needs, as evidenced by the Medical Device Needs Document and Domestic Medical Device Production Capacity Data.: Mekanisme ini akan berlaku untuk produk impor jika kapasitas produksi industri alat kesehatan dalam negeri belum memenuhi kebutuhan nasional, sebagaimana dibuktikan oleh Dokumen Kebutuhan Alat Kesehatan dan Data Kapasitas Produksi Alat Kesehatan Dalam Negeri.

For imported products already listed in the E-Catalog prior to the issuance of KMK RI Number HK.01.07/Menkes/1258/2022 on July 6, 2022, they will not be frozen. Conversely, products added to the E-Catalog after this date (July 6-31, 2022) will be quarantined under the Freeze and Unfreeze processes, with results expected to be released in the first week of August.

The substitution will involve a team of officials from the Ministry of Health, with periodic reviews conducted weekly on imported medical devices slated for Freeze and Unfreeze according to established criteria. Medical devices that have undergone substitution will be evaluated in the Health Sector E-Catalog.

Product Parameter Criteria

Several product parameters that cannot currently be met in Indonesia include:

• Steam sterilizers with chamber specifications greater than 50 liters
• Electrocardiographs (ECG) with specifications of ≥ 8 channels
• Cardiac monitors (including cardiotachometers and level alarms) with specifications of ≥ 5 channels
• Patient examination gloves made of nitrile
• Manual surgical instruments and obstetric-gynecological general instruments with specifications intended for specific procedures, such as biopsy, IUD insertion, etc.
• Glucose test systems – Closed system glucose test strips

This initiative represents a significant step towards strengthening the domestic medical device industry while ensuring the availability of essential medical products in Indonesia.